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Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

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ClinicalTrials.gov Identifier: NCT02848287
Recruitment Status : Unknown
Verified July 2016 by Go Un Roh, Ajou University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Go Un Roh, Ajou University School of Medicine

Brief Summary:

Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA.

Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.


Condition or disease Intervention/treatment Phase
Tonsillitis Drug: normal saline Drug: ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy
Study Start Date : August 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Placebo Comparator: Normal Saline
1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
Drug: normal saline
1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.

Experimental: Ropivacaine
1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
Drug: ropivacaine
1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.




Primary Outcome Measures :
  1. Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission [ Time Frame: 1 min after postanesthesia care unit (PACU) admission ]
    PAED score is assessed


Secondary Outcome Measures :
  1. Face legs activity cry consolability (FLACC) score [ Time Frame: 1 min after postanesthesia care unit (PACU) admission ]
    FLACC score is assessed.

  2. PAED score 10 min after PACU admission [ Time Frame: 10 min after postanesthesia care unit (PACU) admission ]
  3. PAED score 20 min after PACU admission [ Time Frame: 20 min after postanesthesia care unit (PACU) admission ]
  4. PAED score 30 min after PACU admission [ Time Frame: 30 min after postanesthesia care unit (PACU) admission ]
  5. FLACC score 10 min after PACU admission [ Time Frame: 10 min after postanesthesia care unit (PACU) admission ]
  6. FLACC score 20 min after PACU admission [ Time Frame: 20 min after postanesthesia care unit (PACU) admission ]
  7. FLACC score 30 min after PACU admission [ Time Frame: 30 min after postanesthesia care unit (PACU) admission ]


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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of anesthesiologist physical status class I/II
  • tonsillectomy or adenotonsillectomy under general anesthesia

Exclusion Criteria:

  • obstructive sleep apnea
  • developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848287


Contacts
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Contact: Go Un Roh, MD 82-31-219-6435 gone7968@aumc.ac.kr

Sponsors and Collaborators
Ajou University School of Medicine

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Responsible Party: Go Un Roh, Clinical assistant professor, primary investigator, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02848287     History of Changes
Other Study ID Numbers: AJIRB-MED-DRU-16-061
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tonsillitis
Emergence Delirium
Neurologic Manifestations
Nervous System Diseases
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents